Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. — that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
Water Pik, Inc. Recalls Sonic-Fusion® Flossing Toothbrush Product for Possible Health Risk
Water Pik, Inc. is voluntarily recalling its Sonic-Fusion® flossing toothbrush because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Water Pik, Inc. has received consumer reports of product malfunctioning in the U.S.
The recall is applicable only to Sonic-Fusion® products. All other Waterpik® brand flossers and toothbrushes are not affected.
FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure
Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions
Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.
FDA approves the first drug with an indication for treatment of smallpox
FDA today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.
AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad
Papa John’s Salads and Produce of Tolleson, AZ is voluntarily recalling 148 units of the Superfood Salads due to misbranding and undeclared peanuts. The product contains peanuts which are not declared on the product label as packages of peanuts were mistakenly included in the kits instead of cashews.
FDA warns of imposters sending consumers fake warning letters
FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.
Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
FDA Commissioner Scott Gottlieb, M.D., on new drug shortages task force and work towards long-term solutions to prevent shortages
FDA expands its support for states to advance implementation of produce safety activities
FDA expands its support for states to advance implementation of produce safety activities
MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)
MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API). The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December 2017, though our website http://www.mynicnaxs.com. The undeclared drug ingredients found in these products may pose serious health risks because consumers with underlying medical issues may take them without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. API found in FDA samples include the following: